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Shire Initiates Trials for Vyvanse - Analyst Blog

Recently,
Shire
(
SHPGY
) announced the initiation of two phase IV trials of Vyvanse
(lisdexamfetamine dimesylate) capsules. Vyvanse is currently
marketed for attention-deficit hyperactivity disorder (ADHD) in
children, adolescents and adults in the US and Canada. The product
is also marketed in the US as a maintenance treatment for ADHD in
adults.

The two randomized, double-blind and active-controlled studies
will compare Vyvanse with
Johnson & Johnson's
(
JNJ
) Concerta, another commonly prescribed ADHD product, in
adolescents aged between 13 and 17 years. Both trials will enroll a
total of approximately 1,000 patients. The results are expected to
be released by the second half of 2013.

In December 2011, Shire had submitted a marketing application
seeking European approval of Vyvanse for the treatment of children
aged between 6 and 17 years who are diagnosed with ADHD. Shire is
also evaluating the product for major depressive disorder/MDD
(phase III), excessive daytime sleepiness/EDS (phase II), negative
symptoms of schizophrenia/NSS (phase II) and other non-ADHD
indications in adults (phase II).

Out Take

Vyvanse, with $805 million revenues in 2011, is the top revenue
grosser at Shire. As per data provided by IMS Health National
Prescription Audit, Vyvanse enjoys a 17% share of the US ADHD
market. In 2011. Vyvanse's growth of 27% was significantly higher
than the US ADHD market's growth of 10%.

However, we note that competition in the US market increased
significantly in 2011 with the launch of generic versions of
Concerta and
Novartis'
(
NVS
) Ritalin. Moreover, a new drug, Kapvay, was launched by Japanese
pharmaceutical company, Shionogi & Co., Ltd, in 2011.

We currently have a Neutral recommendation on Shire. The stock
carries a Zacks #2 Rank (Buy rating) in the short run.

Shire's recent collaborations and acquisitions (including
Movetis and Advanced BioHealing Inc.) have added immense potential
to its pipeline. With several of its products already facing or
likely to face generic competition, the company's pipeline needs to
deliver.

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